Home / Recalls / Shane Erickson Inc / D-0240-2021

D-0240-2021 Class II Terminated

Recalled by Shane Erickson Inc — Spring Park, MN

Recall Details

Product Type: Drugs
Report Date: February 3, 2021
Initiation Date: December 23, 2020
Termination Date: September 29, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 42,157 bottles

Product Description

IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384. Labeled as a) SAFE-GUARD Products International, b) Safe-WAY JEVCO Wash-Free Hand Sanitizer, c) TRACTION CAPITAL, d) United States Census 2020. UPC 8 19845 00598 5

Reason for Recall

CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.

Distribution Pattern

Nationwide USA and Canada

Code Information

Lot: MFG: 2020/05/10 L/N: 20200510-3